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Discovery May Lead to First Medical Treatment for Celiac Disease

Scott Adams

In 1994 I was diagnosed with celiac disease, which led me to create Celiac.com in 1995. I created this site for a single purpose: To help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives. Celiac.com was the first site on the Internet dedicated solely to celiac disease. In 1998 I foundedÂ The Gluten-Free Mall, Your Special Diet Superstore!, and I am the co-author of the book Cereal Killers, and founder and publisher of Journal of Gluten Sensitivity.

Celiac.com 02/26/2003 - WOODLAND HILLS, Calif., Feb. 19, 2003/PRNewswire
-- Results from a new study may lead to the first medical treatment for
celiac disease, a hereditary digestive disease that can damage the small
intestine and interfere with the absorption of nutrients from food. Celiac
disease sufferers cannot tolerate gluten, a protein that is found in wheat,
barley and rye. Celiac disease affects an estimated one in 250 Americans,
mostly those of European descent, and there is no known medical treatment
or cure.

Zengen, Inc. researchers discovered that a synthetic form of alpha-Melanocyte-Stimulating
Hormone (alpha-MSH) has an anti-inflammatory effect in celiac mucosa,
the inside lining of the intestinal tract that absorbs food into the body.
A naturally occurring molecule, alpha-MSH modulates inflammatory and immune
responses. Data confirming the presence of alpha-MSH in celiac mucosa
suggests the presence of a local reaction of the molecule to control the
inflammatory response elicited by gliadin. Gliadin is the sub fraction
of gluten that acts as a toxin or poison in people with celiac disease;
it causes an immune reaction, resulting in damage to the small intestine
and an inability to digest and absorb nutrients necessary for health and
growth (malabsorption).

The findings, Anti-Inflammatory Effects of alpha-Melanocyte-Stimulating
Hormone in Celiac IntestinalMucosa, appear in the February 20,
2003 issue of NeuroImmunoModulation, the official journal of the International
Society for Neuroimmunomodulation.

Our research suggests that locally-produced alpha-MSH modulates
inflammation and perhaps limits epithelial damage in patients with celiac
disease, stated James M. Lipton, Ph.D., study investigator, chief
scientific officer and director of Zengen. We are particularly excited
by these findings as these data, coupled with abundant evidence of the
anti-inflammatory and anti-infective activity of Zengens novel molecules
based on alpha-MSH, further validate our research and development efforts
in numerous areas including celiac disease. These positive results will
be used to guide further advancements toward clinical use of the molecules.

The study used human celiac mucosa cells in culture. Researchers collected
duodenalbiopsy pairs from 53 adult celiac patients (34 untreated patients
and 19 celiac patients on a gluten-free diet) and 14 normal subjects and
conducted three series of experiments in order to determine: (1) mucosal
immunoreactivity for alpha-MSH and melanocortin receptors (MCRs), and
gene expression of alpha-MSH precursor pro-opiomelanocortin and MCRs;
(2) alpha-MSH and inflammatory cytokine production by duodenal specimens
in vitro, and the influence of synthetic alpha-MSH on such cytokine production,
and; (3) the influence of stimulation with gliadin on alpha-MSH and cytokine
production in vitro and the effect of alpha-MSH on gliadin-stimulated
cytokine production.

Results suggest a localized anti-inflammatory influence based on alpha-MSH
and its receptors: duodenal mucosa showed evidence of alpha-MSH and two
of its receptor subtypes, MC1R and MC5R. Further, alpha-MSH and MC1R immunoreactivity
was more intense in cell specimens from celiac patients and release of
interleukin 6 (a lymphokine that stimulates the inflammatory response)
from gliadin-stimulated duodenal mucosa was inhibited by synthetic alpha-MSH.

Patients suffering from celiac disease currently have no medical
options beyond a lifetime adherence to a strict, gluten-free diet,
added Dr. Lipton. Clearly, if we can control the inflammatory responses
that are a major part of celiac disease and limit the immunosuppression,
this could lead to the first medical treatment to help the millions worldwide
suffering from this genetic disease.

Zengens novel molecules were developed from more than 25 years of original
research in the US, Europe and Asia on peptide molecules derived from
alpha-Melanocyte-Stimulating Hormone (alpha-MSH). James Lipton, Ph.D.,
Zengens chief scientific officer, chairman of the scientific advisory
board and director, and his collaborators first demonstrated that alpha-MSH
possesses anti-inflammatory properties and uncovered the specific activity
of the carboxy-terminal tripeptide region (C-terminal peptide) of the
alpha-MSH peptide. These discoveries led to the development of Zengens
proprietary peptide molecules, including CZEN 002, a synthetic octapeptide.
Zengen is currently conducting phase I/II clinical trials with CZEN 002
in vaginitis.

About Celiac Disease

According to the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) of the National Institutes of Health (NIH), celiac disease
(CD), also known as gluten intolerance, celiac sprue or gluten sensitive
enteropathy, affects an estimated one in 250 Americans. Celiac disease
is a condition in which there is a chronic reaction to proteins called
glutens which causes destruction of the villi in the small intestine,
with resulting malabsorption of nutrients. A genetic disease, it may appear
at any time in the life of a person with a hereditary predisposition.

Celiac disease is often misdiagnosed, symptoms are varied and there is
no current medical treatment or cure. Patients who suffer from celiac
disease currently have only one alternative -- adherence to a lifetime,
gluten-free diet. If left untreated, celiac disease can lead to malabsorption,
which, in turn, can lead to malnutrition. Celiac disease is especially
serious in children and adolescents, who need adequate nutrition to develop
properly. Further, people with celiac disease who dont maintain a strict,
gluten-free diet have a greater chance of developing one of several forms
of cancer, particularly intestinal lymphoma. Other long-term complications
include anemia, diabetes mellitus, hypothyroidism, osteoporosis, seizures
and peripheral neuropathy.

About Zengen, Inc

Zengen, Inc. is a biopharmaceutical company focused on discovering, developing
and commercializing innovative products to treat and prevent infection
and inflammation through application of its proprietary peptide technologies.
Zengens novel molecules offer broad-based anti-infective and anti-inflammatory
solutions for multiple diseases and disorders, ranging from yeast infection
to transplantation, and have the potential to significantly alter the
way these diseases are treated. For more information about Zengen, please
visit www.zengen.com.

Zengen, Inc. Forward-Looking Statement
Disclaimer

This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties.
Such statements reflect managements current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors. The company is developing
several products for potential future marketing. There can be no assurance
that such development efforts will succeed, that such products will receive
required regulatory clearance or that, even if such regulatory clearance
were received, such products would ultimately achieve commercial success.